This Guide provides an excellent practical reference point derived from many years of experience and expertise in designing and running microbiology laboratories. The Guide details what Pharmig considers to be best practice for establishing and operating microbiology laboratories in Pharma and associated industries. The Guide describes considerations to be applied to the design, set up and running of the microbiology unit. The guide includes chapters on:
- Facility design, equipment qualification & maintenance
- Culture media and microorganisms
- Method verification and validation
- Microbiological testing of starting materials, intermediates and finished products
- Rapid methods and specific test methods
- Environmental monitoring
- Documentation and laboratory records
